NCT01446978

Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Sormland County Council, Sweden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx). In a previous study, 2 doses were not considered effective and there is therefore need for a study with an additional dose

Detailed description

Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Activity Score, Acute phase reactant and total immunoglobulin G in plasma). Hepatitis A vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG \> 10mIU/mL.

Conditions

• Vaccine Response Impaired

Interventions

Type	Name	Description
BIOLOGICAL	hepatitis A vaccine	3 doses of hepatitis A vaccine, given at 0+1+6 months
BIOLOGICAL	hepatitis A vaccine	Two doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2011-10-05
• Last updated: 2015-11-18

Locations

4 sites across 1 country: Sweden